A workshop on the design of clinical trials for bronchiectasis treatments was organised by the US Food and Drug Administration (FDA) in June to review their current advice to researchers.
The FDA is responsible for approving the licensing of drugs in the USA. Their decisions can also be important for those working in Europe, because pharmaceutical companies may stop developing their drugs if they are not approved in the USA.
This workshop follows an FDA licensing panel for a potential new bronchiectasis treatment earlier this year – which 12 members of the ELF bronchiectasis patient advisory group (PAG) took part in. Although the drug was not approved, the FDA had committed to reviewing the guidance they provide drugs companies in trials for treatments.
At this workshop, views from our bronchiectasis PAG were presented by Professor James Chalmers (Chair of EMBARC). PAG members were asked three questions to establish their views on clinical trials. The US COPD Foundation also collated responses to the same questions – and there were presentations from patients and carers on the day.
What would you consider the most important endpoint to measure in clinical trials of antibiotics?
The top two answers were:
Would you be willing to do a trial and potentially get placebo (a fake medicine) for 2 years or would you have concerns about this?
How much do you worry about the risk of antibiotics causing resistance in bacteria compared to the potential benefit of antibiotics for treating bronchiectasis?
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